Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma
- Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per
million people per year and has a very poor prognosis with an overall 5-year mortality
rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months.
- The treatment of choice for a localized primary or recurrent tumor is surgical
resection. For unresectable metastatic or recurrent disease, mitotane,
aminoglutethimide, metapyrone, and ketoconazole are used.
- Cisplatin is one of the most effective chemotherapeutic agents for ACC. In the
Surgery Branch we have conducted Phase I and II trials using heated intraperitoneal
(IP) chemotherapy with cisplatin for primary peritoneal mesothelioma, low grade
appendiceal adenocarcinoma, ovarian malignancies, and high grade adenocarcinoma
of the gastrointestinal tract. Synergy has been demonstrated for cisplatin and
- The purpose of this trial is to determine if an aggressive surgical approach with
intraperitoneal administration of heated cisplatin when tumor volume is minimal, can
impact and improve on progression free survival.
- To determine IP progression free survival after optimal debulking and heated IP
chemotherapy with cisplatin in patients with IP spread of adrenocortical cancer
- Determine morbidity of this procedure in this patient population
- Determine the impact of surgery and HIPEC on QOL and hormone excess
- Examine patterns of recurrence (local versus systemic)
- Perform molecular analyses to try to discern if there are intrinsic differences between
tumors that recur widely throughout the peritoneal surface and those that metastasize
to other organs or are confined to a local recurrence.
- Determine overall survival after optimal debulking and heated IP chemotherapy with
cisplatin in patients with IP spread of adrenocortical cancer.
- Histologically proven ACC evalauable by CT imaging with the majority of disease
confined to the peritoneal cavity and surgically resectable to a residual size of less
than 1 cm or amenable to radiofrequency ablation in patients who are > 18 years of
- This is a classic phase 2 trial to determine efficacy of this therapeutic strategy in
ACC. Patients will undergo cytoreductive surgery to achieve a CCR of 0 or 1.
Patients who are successfully debulked will then undergo HIPEC with cisplatin.
Patients will be evaluated by associate investigators in coordination with the Principal
Investigator for eligibility. Due to its exploratory nature, up to 30 patients may be
enrolled to obtain 24 evaluable patients. (Patients must undergo successful debulking
and HIPEC to be considered evaluable.)
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine intraperitoneal progression free survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer.
6 month intervals until peritoneal progression
Marybeth S Hughes, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|